MedicaLyte Bicarbonate Powder REF: DB+201-2.1 recall (Nipro Renal Soultions USA, Corporation)
Medical deviceClass IIOngoing
Summary: Nipro Renal Soultions USA, Corporation is recalling MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)). Reason: Hemodialysis concentrates contain high endotoxin levels.
What is being recalled
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Why
Hemodialysis concentrates contain high endotoxin levels
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama. (states named: Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania)
How to tell if yours is affected
DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3134-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 5, 2026 |
| Reported | September 16, 2026 |
| Company | Nipro Renal Soultions USA, Corporation |
| Company location | Lewisberry, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2,327 cases |
More recalls from Nipro Renal Soultions USA, Corporation · all medical device recalls · recalls from August 2026